| pubmed-article:20875824 | pubmed:abstractText | The analysis of whole blood samples by flow cytometry for pharmacodynamic and biomarker assessments in clinical studies has been limited by the necessity to test these samples within a short time frame after blood collection. In most clinical studies, blood specimens are shipped to a centralized testing facility; it is critical to demonstrate specimen stability over a period of time which will encompass the time elapsed between specimen collection and testing. A possible solution to overcome this limitation is the use of a fixative to preserve the cell surface antigen stability in whole blood. We examined the stability of markers for T lymphocytes (CD3, CD4, CD8, CD45RA, and CD45RO), B lymphocytes (CD19), NK cells (CD16+CD56), activation (CD25 and HLA-DR), chemokine receptors (CCR5 and CXCR3) and skin homing (CLA) in fixed blood over 7 days and used this information to select the markers for global clinical studies. These assays with selected markers were further validated using fit-for-purpose approach (Lee et al., 2006) and to set the sample acceptability criteria for use in clinical sample testing. Most of the markers examined were stable when collected in Cyto-Chex® BCT for one week with the exception of the activation markers on T cells. | lld:pubmed |
